India to bounce back as clinical research hub
India was considered as an all-time favoured destination for clinical trials. Most of the outsourced studies are phase III studies where India has a diverse pool of patients. After 2010 there was major setback in the CRO industry in India. Drug Controller General of India (DCGI) approvals were delayed and multinational sponsors stepped back outsourcing studies to India. But slowly post 2016 DCGI has been generous enough in proving approvals and online application system has brought a lot of difference. Indian Clinical Trial market and clinical trial services is expected to grow significantly along with trends.
With 17% of the global population and 20% of the world’s disease burden, India faces a ‘triple burden’ caused by communicable disease, non-communicable disease and socio-behavioral illness. The increasing disease burden is propelling the pharmaceutical and biotechnology industry to bring up new chemical entities into the market at a higher rate. Most companies are outsourcing the clinical trials of their newly developed drugs to various contract research organizations as this could save them the hassles of regulatory issues and patient recruitment burden from the research and development phase.
Making his point on triple burden of diseases, Naz Haji, SVP & Managing Director, QuintilesIMS India said “We have diseases that are close to being eradicated in other regions like cholera and tuberculosis, and at the same time must contend with rising rates of diabetes, cardio-vascular and other lifestyle-related diseases. Despite this high burden of disease, according to www.clinicaltrials.gov, less than 1.4% of global clinical trials are carried out in India and we need to be doing more for our patients. Besides our large population of treatment-naïve patients, India also has excellent site infrastructure, skilled investigators and cost efficiencies.”
According to Boston Consulting Group, 48% ($30 billion) of all clinical research investment in 2017 will be spent on outsourced services. India is home to 16 per cent of the world’s population, 20 per cent of the global disease burden, yet it has less than 2 per cent of clinical trials registered worldwide.
On the current trends in CRO space, Divya Chandradhara, Director of Bio Agile Therapeutics said “Total number of registered studies worldwide is about 253,462 (as on September 1, 2017) as per clinicaltrails.gov. 5673 trails have been registered on Clinical Trials Registry- India (CTRI) till date. In 2010 when India
“India presents one of the most promising trials arenas available today. Currently, India represents 17% (1/6th) of the world’s population, with genetically diverse patient base in various disease areas (1/5th or 20% of the global disease burden) and only 1-2 % of all global clinical trials. High prevalence of both the developing and developed world provides access to a variety of diseases including access to a large pool of ethnically diverse and often treatment-naïve patients. With a high standard of medical care available via expert clinicians (including those returning western-trained physicians), access to technology and competitive operational costs, India offers an attractive option, for those wanting quality data collected from an internationally harmonized environment.” - Dr Aparna Parikh, Executive Director – Scientific Affairs, Pediatrics & Infectious Diseases, PRA Health Sciences
“We have been working with the DCGI office for the last two years and looking at where the obstacles are, and trying to design the entire pathway of clinical development. This is because we had a number of different stakeholders telling us about the issues they were facing, not only from the commercial side but also from the academic and scientific side, and also the industry. We have now revised the ICMR ethical guidelines, which was last touched upon in 2006. So we have included a lot of new chapters in that, on public health research, use of gene therapy and so on. The draft guidelines will be officially released very soon. The industry will be of course benefited by them. ” - Dr Soumya Swaminathan, Director General, ICMR
was in peak of the getting major MNC studies there was almost 500 trials registered in CTRI, in 2013 it was only 107 studies, in 2014 we have 133 trials registered, in 2015 its about 121 studies, in 2016, 84 studies, in 2017 about 45 studies till date and its slowly picking.”
The percentage of clinical trials registered in diabetes, CAD, asthma, COPD, epilepsy, schizophrenia, malaria, and tuberculosis are more in India compared to other nations. Still India is lagging far behind the western countries as well as other Asian countries like China and Japan in the total number of trials registered.
There are about 400 + companies (multinational and local) in India which have been offering clinical research services. About the number of employees Divya Chandradhara observed that major CROs include more than 20,000 employees worldwide, but many CROs are small, with fewer than 50 employees. Staff includes entry-level Co-ordinators, Associates, Project managers, Medical writers, Data managers, Statisticians.
Though there was a slight slowdown during last five years, the clinical trials industry in India is seeing an upward trend. Sharing her thoughts Dr Chaitra Harsha, Managing Director, Vipragen Biosciences said “There are several reasons behind the positive growth in clinical phase I and phase II trials in India, the least being the proactive approach and business-friendly ‘Make in India’ initiative of the Indian government.”
The recent amendments in the regulatory framework have significantly streamlined the clinical trial review process. Central Drugs Standard Control Organization
“Though India makes up 16% of the world's population and 20% of the world's disease burden, less than 1.4% of global clinical trials are carried out in the country. Of 236,329 ongoing global clinical studies, only 3,016 studies are being done in India, placing it way behind the USA, Europe, Japan, China, Malaysia and Taiwan. The low number ranks India in the fifth position in Asia.” - Dr Chaitra Harsha, Managing Director, Vipragen Biosciences
(CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, and serves, has initiated online submission of applications and monitoring of clinical trials in the country in order to improve transparency, accountability and efficiency in processing of trials. The application and review process needs to be made simpler with fewer administrative hurdles and less uncertainties associated with the approval timelines. Faster approval timelines would make it conducive for more clinical studies to be conducted in India.
Though DCGI has made the application process simpler compared to previous and reduced the timeline for getting approval the number of studies conducted is still not significant. There are many other issues that need immediate attention of the regulatory agencies.
Referring to the issues Dr Chaitra Harsha said “There is a lack of awareness among the researchers regarding the registration of clinical trials in clinical trial registries. Another reason could be the availability of a limited number of recognized courses for training physicians and other healthcare professionals involved in the conductance of clinical trials, resulting in shortage of trained manpower.”
Hence to meet the growing demands of clinical research and to increase the number of registered trials in the country, she suggested that India needs to train more qualified, ethical clinical investigators, skilled nurses and biostatisticians to suit the clinical trial appraisal. With experienced clinical researchers and technological developments, India is sure to contribute as a major clinical trial destination for the global clinical research in the near future.
On challenges before the CROs, Dr Aparna Parikh, Executive Director – Scientific Affairs, Pediatrics & Infectious Diseases, PRA Health Sciences said “Ethics Committees (ECs) have been empowered to regulate clinical research at each individual study site and are responsible for safeguarding the rights and safety of research participants. It is therefore important to ensure that these ECs have trained manpower, adequate standard operating procedures, sufficient administrative support and compliance with Schedule Y requirements. Also, the high recruitment in India can challenge both the sites and the study monitors as struggle to keep up. Hence the need to select sites with trained investigators, site staff and accredited ethics committees. As clinicians and sites in the major metros get busier with more and more clinical trials, it is important to develop newer sites by educating and training investigators, clinical research professionals and ethics committee members.”
Outcomes of global inspections in recent past (data integrity and GCP violations), lack of conducive regulatory framework, knee-jerk implementation of regulations, delays in clinical trial permissions, crossparticipation risk (BA/BE studies), need of streamlining clinical research processes and close collaboration of all stakeholders in the ecosystem are the other issues that need serious attention said Dr Shrinivas Savale, Pharmaceutical and Biopharmaceutical Consultant, Ahmedabad.
“I think the biggest challenge we have in India is the need to restore confidence and trust amongst
“Previously due to regulatory approval delays some sponsor companies were diverting to conduct their trials in countries like China, Taiwan and Malaysia going by their expertise and speedy clearances. One exciting development is that approvals for clinical trials are now taking about six to seven months, which is the global standard. It used to be 15 months in India a couple of years back.” - Divya Chandradhara, Director, Bio Agile Therapeutics
global stakeholders in doing research in India. We have come out of a very challenging regulatory environment and now have regulation that is scientific, balanced and patient-centric. Our regulators are committed to bringing trials back to India and it is a responsibility that all stakeholders have to play a role in so that our patients have access to the best and newest treatment and therapies. It is also important that we create more awareness about the high quality of clinical research
“Indian companies need to focus on quality. Greater emphasis and consistent outlook on all aspects of quality is essential to gain recognition in the global platform. From the regulatory perspective, even though much has been done in the last couple of years there is space to improve on the level of clarity that is needed on certain issues and also on the trained manpower needed to implement the plans.” - Dr Saral Thangam, CEO & Managing Director, Norwich Clinical Services
done in India. It is unfortunate that the one or two instances of transgression that we read about in the media seem to drive the narrative around clinical research in our country. There is so much of high quality clinical research being done in India and we must ensure the world knows about it,” Naz Haji of QuintilesIMS India added.
Dr Aparna Parikh further observed that media can play a major role to support clinical research in India by educating the public on research and development and disseminating accurate information about clinical trials. Both media and patient support groups can help promote public awareness and engagement to increase the trust, support, participation in clinical research and thus patients gain access to safe and effective new treatments for unmet medical needs. Adverse media reports, long, uncertain regulatory approval timelines will only delay introduction of new and relevant therapies, worsening the problem of drug lag in our country.
Global companies lack trust in Indian CRO’s due to data quality issues created by few CRO’s. Ethics committee approval for studies is one of the challenge. Divya Chandradhara, said that maintenance of high quality data, improvements in infrastructure, accommodative regulatory environment, will play major role in improving the Indian market size in clinical research.
There is definitely a need to safeguard the interests of research participants. Dr Shrinivas Savale observed that the sector being highly regulated strict compliance to the good clinical practice (GCP), good laboratory practice (GLP) and other good practices need to be monitored and verified by qualified people/regulatory inspectors. Media also needs to be sensitive to this industry emphasizing on the larger benefits of clinical research. Most importantly all the contributing players for core and supporting roles need to commit for maintaining the high standards of conduct clinical research, with
“Given the supportive regulatory environment we now have in India and the commitment from regulators to encouraging more clinical research in the country, the outlook for clinical research is positive. We are likely to also see a lot more local innovation and R&D for illnesses prevalent in our country which bodes well for our patients. We are also likely to see, as in the rest of the world, greater adoption and integration of technology and data and analytics in the conduct of clinical research.”
- Naz Haji, SVP & Managing Director, QuintilesIMS India
ethics and quality at its centre, year-on-year.
In spite of the many challenges, opportunities and strengths India has, will help it to bounce back from a troubled period that the industry has experienced in 2013-14 for conducting clinical trials. Dr Saral Thangam, CEO & Managing Director, Norwich Clinical Services said “There have been considerable improvements from the perspective of timelines, and predictability of outcomes for clinical trial applications. There are multiple positive initiatives by the government bodies to engage the stakeholders. Several of the rules that were impeding trial conduct in India have been repealed or modified to allow a reasonable clinical trial framework to emerge.”
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With recent setbacks in the international regulatory scrutiny has cost dearly to the sponsors globally and
the ‘noncompliant and integrity lapses’ have created a huge negativity about Indian clinical research sector. “There is a need for concentrated efforts from all the stakeholders, especially CROs who have been performing the world-class research for last couple of decades and regulatory agency ensuring transparent and robust system as well as conducive regulatory atmosphere safeguarding interests of all contributors, to improve the image of Indian Clinical Research industry. These efforts have started reflecting with positive outcomes of regulatory inspections at the CROs and sites as well as changes in the regulatory systems. Definitely the industry will bounce back in next 5-7 years,” Dr Shrinivas Savale said.
The industry players are optimistic about the growth of the industry in the coming years. Given the mere population of the country and the disease burden, India qualifies to be major clinical research hub in the years to come. The other major reasons for the same are simplification of regulatory procedures; latest proactive steps taken by the government; encouragement to local stakeholders in clinical research and global incentives to grow, sums up Dr Chaitra Harsha.
Making her point Divya Chandradhara said “India has the potential to establish itself as a hub for global clinical trials. Emerging technologies, quality output and
“Recent actions from regulatory authorities – automation/ online submission of applications, smoothening the process of import/export of biological samples, registration of ethics committees, scientific approach to granting the permission for first-in-man studies on case-by-case basis, improved regulatory vigilance of regulatory agency and recruitment of competent regulatory staff/training of the staff to update the skills and understanding in the clinical research – indications of improving the clinical research ecosystem and boosting the sector.” - Dr Shrinivas Savale, Pharmaceutical and Biopharmaceutical Consultant, Ahmedabad
faster trial approvals will help us to achieve the goal.”
“It must be recognised that all stake holders have a role to play in this. Indian pharma companies, CROs, Ethics committees, regulators, the public and the media have to act in a responsible and sustainable manner to support clinical research in India. The announcement of ICMR regarding the sharing of data is definitely a
positive step forward,” Dr Saral Thangam added.
With regulatory reforms in place, India is certainly once again on an upward cycle as its appeal to both international and local sponsor companies recognize the advantages and opportunities available. The understanding of trials continues to grow in this relatively young trial arena providing strong data quality to match its recruitment abilities.
“India will continue to increase in appeal as it increases its culture of quality alongside its protection of patient safety maturity in the trials arena. Improved regulations, training and education of research professionals, increased base of qualified and trained investigators and supporting staff, high quality data will once again make India an attractive destination for global clinical trials,” concludes Dr Aparna Parikh, of PRA Health Sciences.